Pharmacokinetics, Pharmacodynamics and Safety Study of Z-213 to Iron Deficiency Anemia

Phase Ib Study of Z-213 in Subjects With Iron-deficiency Anemia - To Investigate the Safety, Tolerability Pharmacokinetics and Pharmacodynamics -

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02170311

Enrollment

Registered

2014-06-23

Start date

2014-06-30

Completion date

2015-03-31

Last updated

2015-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Deficiency Anemia

Keywords

Z-213, Ferric carboxymaltose, Iron, Iron-deficiency-anemia

Brief summary

The safety, tolerability, pharmacokinetics and pharmacodynamics of Z-213 will be investigated in patients with iron-deficiency anemia after administration of a single dose (100 mg, 500 mg, 800 mg or 1,000 mg iron).

Interventions

DRUGZ-213

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

Inclusion criteria

* Patients with mild iron deficiency anemia

Exclusion criteria

* Patients with anemia caused by conditions other than iron deficiency * Patients with abnormal laboratory test values at screening for C-reactive protein, Serum phosphorus, Aspartate aminotransferase, Alanine aminotransferase, Total bilirubin * Patients with liver, kidney or circulatory system disease * Patients with a history or present illness that is a malignant tumor or autoimmune disease * Patients who underwent intravenous administration of an iron preparation, administration of an erythropoiesis stimulation agent or blood transfusion within 8 weeks before the screening * Patients who underwent oral administration of an iron preparation (including an over-the-counter drug or supplement) within 4 weeks before the screening

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics of total serum iron (Cmax), (Tmax), (AUC0-t), (AUC0-24),(AUC0-72),(T1/2), (CL), (Vd, area), (Vd, ss), (MRT) or total urine iron (CLren), (Ae).	8days

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026